Two local biotechnology companies — Iterion Therapeutics and Moleculin Biotech — began clinical trials for drug candidates Oct. 19. Here's a look at how these Houston-based companies are moving through the regulatory pipeline:
Iterion Therapeutics
Houston-based oncology firm Iterion Therapeutics Inc. is initiating clinical trials for its lead drug candidate with the University of Texas M.D. Anderson Cancer Center.
Iterion Therapeutics is investigating its lead clinical candidate, Tegavivint, as a potential treatment for acute myeloid leukemia, the biotechnology company announced Oct. 19. Dr. Tapan M. Kadia from M.D. Anderson's Department of Leukemia is leading the Phase I clinical trial, the company announced.
Iterion's drug candidate had previously undergone a proof-of-concept Phase 1 study in desmoid tumors, but the firm is expanding to explore applications in other cancers, like acute myeloid leukemia, non-small cell lung cancer and forms of pediatric cancer, Rahul Aras, CEO of Iterion.
Each of these cancers are characterized by nuclear beta-catenin over-expression, according to the company. Tegavivint acts as a nuclear beta-catenin inhibitor, preventing the activation of the cancer genes while allowing the beta-catenin to resume its normal role in tissue function.
"We are very excited about this trial to research Tegavivint as a potential new treatment for AML, the most common type of leukemia in adults," said Aras.
Earlier this year, Iterion announced raising a $17 million Series B funding round to fuel its clinical trial efforts.
Iterion is headquartered within the TMC Innovation Institute at 2450 Holcombe Blvd.
Moleculin Biotech
Houston-based Moleculin Biotech Inc. (Nasdaq: MBRX) reported interim results from a Phase 1b/2 clinical trial for its drug candidate Annamycin in treating soft tissue sarcoma lung metastases.
Annamycin is an anthracycline developed to treat acute myeloid leukemia. Based on preliminary data from two cohorts in the trial demonstrated 80% clinical activity — four of the five patients enrolled demonstrated a response to treatment. One patient had "a substantial (>30%) reduction in tumor size," said Walter Klemp, chairman and CEO of Moleculin.
The Phase 1b portion of the study is evaluating the maximum tolerated dose and the safety of Annamycin. The Phase 2 portion will study the efficacy of Annamycin in treating subjects with soft tissue sarcoma with lung metastases who have failed prior chemotherapy.
Separately, Moleculin announced Oct. 19 that it had received approval from the Medicines and Healthcare Products Regulatory Agency in the U.K. to begin a Phase 1a clinical trial of Moleculin's drug candidate WP1122 for treating patients with Covid-19.
The Phase 1a study will explore safety and pharmacokinetics in healthy human volunteers, while future development will investigate effects on patients infected with Covid-19, Moleculin said.
"Coronaviruses, including SARS-CoV-2, are highly dependent upon glycosylation to form structurally and functionally different essential glycoproteins, as well as glycolysis for energy production," said Klemp. "The potent antiviral effect demonstrated by WP1122 in preclinical models to-date is encouraging and bolsters our belief in its potential as an effective therapy for Covid-19."
